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A Prospective UK Multicentre Study of Kidney Donors
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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ClinicalTrials.gov Identifier: NCT01769924
Verified January 2013 by Jonathan N. Townend, University Hospital Birmingham NHS Foundation Trust. Recruitment status was: Not yet recruiting
: January 17, 2013
Last Update Posted
: January 17, 2013
Cambridge University Hospitals NHS Foundation Trust
British Heart Foundation
University Hospital Birmingham NHS Foundation Trust
North Bristol NHS Trust
University Hospitals Coventry and Warwickshire NHS Trust
Kings Health Partners
Glasgow Western Infirmary
Belfast Health and Social Care Trust
Sheffield Teaching Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Jonathan N. Townend, University Hospital Birmingham NHS Foundation Trust
Studies of patients with established kidney disease, even when this is mild, appear to show that they are at high risk of heart failure, stroke and sudden cardiac death. This may be because kidney disease causes stiffening of the arteries in the body which means that the heart and brain are damaged by high blood pressure. By studying patients before and after the removal of a kidney (uni-nephrectomy) for transplantation the investigators will find out for the first time in man the effect of an isolated reduction in kidney function on the structure and function of the cardiovascular system.
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Ages Eligible for Study:
18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
A donor group will be recruited from all patients undergoing donor nephrectomy.
A contemporaneous control group will be recruited from clinics, advertisements within and outside the institutions and from any local volunteer databases.
These will be the same for donors and controls. The current nationally set exclusion criteria for donors include age/glomerular filtration rate (GFR) cutoff, diabetes mellitus, any history of cardiovascular or pulmonary disease, evidence of hypertensive end-organ damage, known left ventricular dysfunction (including ejection fraction < 40%) and atrial fibrillation.